Safety Aggregate Report Manager / Senior PV Scientist (Pharmacovigilance)

Location: Belgrade, Serbia

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Act as a stand-alone global functional lead for safety aggregate reporting, signal management, and literature surveillance projects.
• Lead, author, finalize, and quality-check PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings, and regulatory responses.
• Conduct and oversee literature safety surveillance, signal detection, validation, evaluation, and risk characterization for marketed and investigational products.
• Set up and lead safety management teams, signaling strategies, project documentation, metrics, and compliance activities.
• Support audits and inspections, maintain project readiness, and provide reports on project metrics, scope changes, and client requests.
• Provide training, mentoring, consultative guidance, and process-improvement support to SARA staff and cross-functional stakeholders.

Requirements

• Life science, pharmacy, nursing, healthcare, or pharmacovigilance-related education and experience.
• 5–10 years of relevant pharmacovigilance experience, including drug safety, aggregate reports, and preferably signal detection or signal management.
• Strong written and verbal communication skills.
• Strong organizational and time-management skills, with the ability to meet strict deadlines and manage competing priorities.
• Fluent English, spoken and written.

Culture & Benefits

• Full-time employment in a global, cross-functional pharmacovigilance environment.
• Collaboration with regulatory, medical writing, clinical research, quality, safety operations, and technology functions.
• Opportunities to mentor colleagues and contribute to global and local operational initiatives.
• Focus on continuous process improvement, standard operating procedures, documentation quality, and audit readiness.